Disclosure and transparency of clinical trial information is taking on new dimensions, resulting in trial sponsors and research organisations facing a host of new requirements in the EU, US, and other places in the world. This 2018 Conference builds on prior conference discussions and leverages learnings from International experts, providing the opportunity to gain insights on how to meet the new challenges and opportunities. The program is assembled around key themes:
- Upcoming implementation of the EU Clinical Trial Regulation: Portal and Database Status/Updates
- Operational tools and strategies sponsors are using to comply with EMAs Clinical Data Publication Policy 0070
- Best practices in meeting the expanded requirements of the NIH Final Rule for FDAAA (42 CFR Part 11)
- Legal requirements related to disclosure of clinical research information for medicinal products and medical devices
- How the new ICMJE data sharing requirements are being implemented
- Impact of the EU General Data Protection Regulation (GDPR) on data sharing
- Approaches to navigating and complying with global disclosure and transparency requirements
Attendees will learn from case studies and the experiences of experts and their peers.
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DIA is going green: what about you?
In 2018, DIA is going paperless. No printed programme will be distributed onsite, so please make sure to download the app in advance.
The DIA Global App is designed to enhance your meeting experience and provide valuable information in one place. Search "DIA Global" in your app store.
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Short Course or Primer
To keep you at the forefront.
Virginia Acha, PhD, MSc AVP, Global Regulatory Policy
Merck Sharp & Dohme LLC, United Kingdom
Merete Joergensen, MBA, MSc Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, Denmark
Robert Paarlberg, MS Principal
Rebecca Williams, PharmD, MPH Senior Clinical Trials Subject Matter Expert
Essex, A Veridix AI Company, United States
Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
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